Safe Biologics

NOVEMBER 12, 2023

6 would prevent the HHS Secretary from requiring a switching study as part of the data package to receive the interchangeable designation. However, S.6 This would inappropriately limit the FDA’s authority to determine what data is scientifically appropriate for a particular biosimilar to provide in order to receive the designation.

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Biosimilars Drug Pricing Packaging Labelling 130

Pharma in Brief

MARCH 18, 2021

Health Canada is seeking input from industry stakeholders on a new draft guidance document that discusses the use of electronic media in prescription drug labelling. A drug’s “label” can include its inner or outer labels, a package insert, or its product monograph ( PM ). Guidelines for electronic labelling.

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European Pharmaceutical Review

MARCH 14, 2023

This concerns the quantity of the medicinal product in the packaging, ie, the increase or decrease in the number of units of the product in the outer packaging according to local demands and its labelling, including the leaflet, which should be in the language of the country into which the product is imported.

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Packaging Generic Medicine Labelling Pharmaceutical Companies 98

European Pharmaceutical Review

JANUARY 23, 2023

In addition, MSSG supports temporary national measures such as unit dose dispensing and compounding.

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Packaging Labelling Compounding Communication 98

FDA Law Blog: Biosimilars

AUGUST 17, 2023

Vanda requested that FDA revoke the approval of Apotex’s and Teva’s generic versions of Hetlioz on the grounds that the generic tasimelteon products did not meet the statutory “same labeling” requirement for generic drugs found in 21 U.S.C. § Vanda’s Hetlioz was, in fact, the first FDA-approved drug product to include braille labeling.

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Pharma in Brief

AUGUST 9, 2021

The Minister would also have the ability to suspend the sale of an individual lot where there is evidence that it would present an unacceptable risk to Canadians’ health and safety, rather than suspend the drug’s authorization. The amendments contemplate labelling flexibilities for special containers. On-site Evaluations.

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Labelling Packaging Biosimilars 98

GMPSOP

AUGUST 11, 2024

Documentation : Keeping detailed records of orders, specifications, manufacturing processes, packaging, and labeling to ensure traceability and compliance. Packaging and labeling operations for investigational products are often complex and must meet specific requirements to ensure the integrity of clinical trials.

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Packaging Documentation Labelling Dosage 52

GMPSOP

MARCH 30, 2024

Proper line segregation involves physically separating different lots of starting materials, labeling components, and printing matters, many of which look similar. Different products should not be packaged in proximity unless physical segregation exists. Please look at the labeling operation in the picture below.

Labelling 52

Labelling Packaging Documentation Pharmaceutical Manufacturing 52

Pharma Marketing Network

AUGUST 9, 2023

Maintain a balanced approach by presenting both the benefits and potential risks of the medication or treatment. Adhere to Labeling and Packaging Requirements The labeling and packaging of pharmaceutical products are tightly regulated to ensure safety and accurate information.

Labelling 52

Labelling Packaging Communication Pharmaceutical Companies 52

Eye on FDA

AUGUST 22, 2023

The Untitled Letter posted this week involved an oral birth control pill which has a specific of contraindications contained in the label as well as a list of warnings and precautions and of the most common adverse events. First, while presenting the indication in the posting, there was no risk information included in the communication.

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Express Pharma

JUNE 28, 2023

The value of India’s retail pharmaceutical market is estimated to touch $59 billion by the fiscal year 2023, which presents a promising opportunity for retail pharmacies to bolster and strengthen their operations. However, a management system can help ensure the security and availability of all medicine stocks, resulting in cost savings.

Online Pharmacies 98

Online Pharmacies Customer Service Data Entry Packaging 98

Pharma Marketing Network

AUGUST 9, 2023

Maintain a balanced approach by presenting both the benefits and potential risks of the medication or treatment. Adhere to Labeling and Packaging Requirements The labeling and packaging of pharmaceutical products are tightly regulated to ensure safety and accurate information.

Labelling 40

Labelling Packaging Communication Pharmaceutical Companies 40

GMPSOP

SEPTEMBER 22, 2022

Acceptable Quality Limit is used to make an informed decision whether to accept or reject an incoming packaging components lot by assessing the lot size and types of defects found during a pre-determined level of inspection. 4.0%) A defect that is not likely to materially reduce the usability of the product for its intended purpose.

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Packaging Documentation Labelling 52

European Pharmaceutical Review

SEPTEMBER 2, 2022

The call for transparency in the presentation of study sampling methodology should not be limited to RMM effectiveness studies. The sampling strategy must be supported by sound and properly cited sources whose conclusions must be presented as supportive elements in the study documents. Any additional comments?

Adverse Reactions 96

Adverse Reactions Documentation Medical Schools Packaging 96

GMPSOP

FEBRUARY 25, 2023

Starting materials are processed, sampled, tested, packaged, and released before the finished products are stacked on pharmacy shelves. Sampling is carried out on intermediate processed materials and tested to ensure those are formulated correctly, free from contamination and qualified for filling and packaging. as their visual aids.

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Labelling Packaging Documentation Pharmaceutical Manufacturing 52

FDA Law Blog: Biosimilars

JULY 10, 2023

We will then present an effective strategy to address FDA’s AI request in a timely manner. However, the strategy of addressing the AI request presented in the next section of this blog post applies to all three types of 510(k)s. For labeling documents and the 510(k) summary, FDA often requests both clean and redlined versions.

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Documentation Packaging Communication Labelling 75

FADIC

JULY 14, 2024

OTC drugs come in various forms, including tablets, capsules, creams, and liquids, and are generally labeled with clear instructions on proper usage and dosage. The FDA’s website provides a wealth of information on OTC drugs, including product labels, warnings, and recalls.

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Adverse Reactions Dosage Mayo Clinic Medical Schools 105

Pharmaceutical Technology

JUNE 18, 2025

Subjects who conclude the trial will be qualified for an open-label extension trial. With no approved treatments available, present management strategies focus on symptomatic treatments and lifestyle modifications, which fall short of addressing the disease’s profound and persistent effects.

Communication 52

Communication Hospitals Packaging Labelling 52

ID Stewardship

OCTOBER 14, 2024

Read all about this in the product label here. More information on ganciclovir in the label here. The process is detailed in the package insert here. Also fun fact, IV SMX/TMP does not require refrigeration once mixed, so it gets a “DO NOT REFRIGERATE” sticker, at least that is more convenient. Well, maybe not.

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Labelling Compounding Packaging Hospitals 52

Pharma in Brief

NOVEMBER 20, 2023

Instead, the Natural Health Products Regulations ( NHP Regulations ) govern the sale, manufacture, packaging, labelling, importation, distribution, and storage of natural health products. In the redetermination, the key question was whether Resolve’s active ingredient is a naturally-present constituent of passionflower.

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Labelling Packaging 52

Pharmaceutical Technology

NOVEMBER 7, 2022

As a vertically integrated company, SHL Medical prides itself on being an end-to-end partner, offering in-house capabilities at every stage – from design, development and production to final assembly, labelling and packaging. Palmetto in North Charleston was the last one, and they did a fantastic presentation for us.

Packaging 52

Packaging Labelling 52

GMPSOP

MAY 26, 2023

– Assessment of packaging and labeling components. computer systems): Make a separate preliminary technical assessment prior to presenting it to the change committee. Printed packaging components are subjected to frequent changes which may require changes in the registration dossier. date, dependencies, etc.).

Documentation 52

Documentation Packaging Communication Customer Service 52

GMPSOP

MAY 26, 2023

– Assessment of packaging and labeling components. computer systems): Make a separate preliminary technical assessment prior to presenting it to the change committee. Printed packaging components are subjected to frequent changes depending on the approved changes in the registration dossier.

Documentation 52

Documentation Packaging Communication Customer Service 52

Express Pharma

MARCH 23, 2023

Pharmaceutical packaging has come a long way in recent years. The industry constantly innovates to provide the most reliable and efficient packaging solutions, from automated assembly lines to shrink-wrap and other state-of-the-art technologies. Different types of pharma packaging include blister packs, bottles, and capsules.

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Packaging Labelling Vaccines 111

GMPSOP

DECEMBER 6, 2024

All waste generated during the cleanup should be disposed of properly in labeled bags, and the equipment used must be cleaned and stored appropriately. Examples include oil leaks from equipment in a packaging line or small solvent spills in the printing and labeling machine. formalin) present a threat due to vapors.

Health and Personal Care Stores 52

Health and Personal Care Stores Labelling Documentation Packaging 52

Express Pharma

MARCH 23, 2023

Pharmaceutical packaging has come a long way in recent years. The industry constantly innovates to provide the most reliable and efficient packaging solutions, from automated assembly lines to shrink-wrap and other state-of-the-art technologies. Different types of pharma packaging include blister packs, bottles, and capsules.

Packaging 98

Packaging Labelling Vaccines 98

Birth Control Pharmacist

SEPTEMBER 20, 2021

Breakthrough bleeding was present in 33.8% While not stated in the current package insert, data are emerging that support fewer breast tissue effects and breakthrough bleeding than older oral contraceptives. Nextstellis (Drospirenone and Estetrol) [package insert]. of the E4/DRSP group group versus 47.8% of the E2 V/DNG group.

Adverse Reactions 52

Adverse Reactions Packaging Labelling Diabetes 52

The Thyroid Pharmacist

SEPTEMBER 6, 2023

Personal Care : The Wellnesse line of haircare and toothpastes by Katie Wells (aka the “Wellness Mama”) contains high-quality, safe ingredients that are clearly labeled, so there are no surprises! Coffee : Mold toxins can be present in some coffee, and I love Dave Asprey’s commitment to creating mold-free coffee.

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Health and Personal Care Stores Packaging Labelling Compounding 94

RX Note

SEPTEMBER 23, 2023

In MDIs, drug is either dissolved or suspended in liquid propellant(s) together with other excipients, including surfactants, and presented in a pressurized canister fitted with a metering valve. Introduction Metered-dose inhalers (MDIs) were introduced in the mid-1950s and are the most commonly used inhalation drug delivery devices.

Packaging 52

Packaging Labelling 52

Quality Matters

APRIL 26, 2023

Ingredient and product quality assurance The potential for variation in medical product manufacturing, distribution and regulatory capability across regions and economies can present challenges to ensuring quality and pose threats to patient safety and public health.

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Prescription Filling Generic Medicine Packaging Labelling 52

Pharmaceutical Technology

NOVEMBER 25, 2022

The API present at 20% was formulated for immediate release, whereas the API that comprised 80% of the total was formulated as extended release over 24 hours. These types of scenarios become even more complicated when one of the two drugs must be released before the others. Faster to market.

Dosage 52

Dosage Pharmaceutical Companies Pharmaceutical Companies Packaging 52

GMPSOP

OCTOBER 28, 2023

Packaging material specifications In the pharmaceutical industry, the requirements for pre-printed packaging materials must be well-defined and documented to ensure that you get the items you specified or ordered and that there are no mix-ups. A standard name and a unique item code define packaging materials.

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Documentation Method Validation Packaging Data Entry 52

Pharmaceutical Technology

JUNE 20, 2023

It plans to work with the FDA to plan new analyses and further develop a new application package. Data presented was drawn from the first 100 patients enrolled in F2G’s Phase IIb, single-arm, open-label trial (NCT03583164).

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Packaging Labelling Communication 52

PharmaShots

APRIL 5, 2023

Udenyca is also indicated to increase survival in patients acutely exposed to myelosuppressive doses of radiation The approval was based on the comprehensive analytical data package, along with a PK, PD, and immunogenicity study.

Biosimilars 49

Biosimilars Packaging Labelling Hospitals 49

GMPSOP

MARCH 17, 2023

In a packaging line, a printer was used to imprint manufacturing and expiry dates on a batch of empty cartons which will be used to fill tablet strips. Further to corrective action, the defective packaging (carton) lot was destroyed which was initially quarantined. A fresh lot of unprinted cartons was issued for printing.

Documentation 52

Documentation Packaging Process Improvement Pharmaceutical Manufacturing 52

The Thyroid Pharmacist

AUGUST 19, 2022

10) All three are required to be present for an autoimmune condition to manifest. pylori is present. pylori on the GI-MAP (not just what the lab showed to be positive), it ended up being 33 percent of people that had the pathogen present. MegaGuard and PyloGuard provide doses on the package. I’ve had H. pylori infection.

Health and Personal Care Stores 98

Health and Personal Care Stores Immunization Immunity Dosage 98

LifeProNow

JANUARY 18, 2025

Data collected through the second quarter of 2024 and presented at the European Society for Medical Oncology (ESMO) 2024 Congress as alate-breaking oral presentationshowed an 83.5 The submission of this innovative intravesical drug releasing system is supported by data from the Phase 2b SunRISe-1 registration study.

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